Advanced Neuromodulation Systems Announces IDE Approval to Investigate Libra(TM) DBS System for Essential Tremor
March 22 2005 - 7:30AM
PR Newswire (US)
Advanced Neuromodulation Systems Announces IDE Approval to
Investigate Libra(TM) DBS System for Essential Tremor DALLAS, March
22 /PRNewswire-FirstCall/ -- Advanced Neuromodulation Systems, Inc.
(NASDAQ:ANSI) (ANS) announced today that it has received an FDA
Investigational Device Exemption (IDE) approval to implant 160
patients at 12 sites to investigate the safety and efficacy of the
ANS Libra(TM) Deep Brain Stimulation (DBS) System to treat
Essential Tremor. The company has identified a number of sites for
the clinical study. The first implants of the Libra IPG System are
anticipated to occur in the second quarter of this year. The
company also announced the submission to the FDA of an amendment to
its IDE application to investigate the ANS Libra DBS System to
treat Parkinson's disease. ANS anticipates receiving this IDE
approval from the FDA in the second quarter. "This approval
represents a major milestone for ANS. Historically, we have focused
on neurostimulation to treat chronic pain, and we intend to
continue to grow that core franchise. With this approval, we now
have the opportunity to move into the deep brain stimulation arena.
DBS presents numerous new growth opportunities for our platform
technologies to address various neurological conditions. We've been
working on our DBS project for a long time, and it is exciting and
satisfying to see it coming to fruition," said Chris Chavez, ANS'
President and CEO. "Estimates of the prevalence of these conditions
vary significantly, but it is generally estimated that
approximately 5 million people in the United States alone suffer
from Essential Tremor, and approximately 1.9 million people in the
U.S. suffer from Parkinson's disease. An independent market
research firm estimates that the market for DBS for these
indications will grow to approximately $180 million by 2008 and
will continue to grow as improvements in the procedure and
stereotactic targeting are made. "The neuromodulation market as a
whole is expected to surpass the billion-dollar milestone this
year, and promises to become a multi-billion dollar,
multi-indication segment of the medical device industry. We are
aggressively investing in both product development and clinical
trials to leverage our platform technologies into emerging clinical
applications for neuromodulation, applications that we believe will
fuel strong organic growth for years to come. In addition to
Essential Tremor and Parkinson's disease, we are systematically
incubating such promising new indications as Migraine, Depression,
Pelvic Pain, Obesity, Tinnitus and Traumatic Brain Injury," Chavez
said. DBS for Depression The company recently announced that it has
acquired exclusive rights to intellectual property covering a
unique method of treating chronic treatment-resistant depression
through DBS. The highly-respected neuroscience journal Neuron
recently reported clinical results in a depression research study
using this method of deep brain neurostimulation. Authored by noted
clinical researchers including the inventors, the article reports
"a striking and sustained remission of depression in four of six
patients." ANS acquired the exclusive rights to this intellectual
property over a year ago. The research study was conducted
independent of ANS and without ANS funding at the University of
Toronto using the Medtronic DBS device. Based on their preliminary
observations that a particular region of the brain (the subgenual
cingulate region, or Broadmann area 25) is metabolically overactive
in treatment-resistant depression, the investigators studied
whether electrical stimulation of that region could reduce the
elevated activity and produce clinical benefit. Six patients with
refractory depression were implanted and followed for six months.
Continuous stimulation of these specific brain structures
"demonstrated that high-frequency DBS of the [target area] can
produce striking behavioral changes in patients with TRD," the
article reports. In addition, "sustained clinical improvement
decreased with blinded discontinuation of chronic DBS and were
recaptured with reinstitution of stimulation, providing evidence as
to the specificity of DBS-mediated changes." The investigators
noted that the antidepressant effects were accompanied by a marked
reduction in local cerebral blood flow as well as changes in
downstream limbic and cortical sites that were measured using PET
scans, meaning that the effects of stimulation can be visually
observed and recorded. The investigators stated that the study
suggests that disrupting brain circuitry in this region by using
electrical stimulation "can effectively reverse symptoms in
otherwise treatment-resistant depression." Treatment-resistant
depression, or TRD, is a severely disabling disorder with very
limited proven treatment options once multiple medications,
psychotherapy and electroconvulsive therapy have failed. The
National Institutes of Health (NIH) estimate that 9.9 million adult
Americans suffer from major depressive disorder. Research indicates
that approximately 20% of these patients are resistant to existing
treatments. Approximately 100,000 people in the United States are
treated with electroconvulsive therapy (ECT) each year. "We will be
quick to caution that these results cover only six patients,
follow-up was limited, and no sham surgery or systematic placebo
control arm was used. Despite these and other limitations in this
research study, the response rate in these patients is striking
given their extreme resistance to other treatments and the
well-documented low placebo response in these patients. What is
particularly impressive is the sustained response in four of the
six patients. Based on the strength of this research study, we are
pursuing a multi-center feasibility study to further evaluate
efficacy, and if the expanded study continues to impress, ANS
intends to pursue a pivotal trial for this important application,"
said Chris Chavez, President and Chief Executive Officer of ANS.
About Advanced Neuromodulation Systems Advanced Neuromodulation
Systems designs, develops, manufactures and markets implantable
systems used to manage chronic intractable pain and other disorders
of the central nervous system. Additional information is available
at http://www.ans-medical.com/ . "Safe harbor" statement under the
Private Securities Litigation Reform Act of 1995: Statements
contained in this document that are not based on historical facts
are "forward-looking statements." Terms such as "plan," "should,"
"would," "anticipate," "believe," "intend," "estimate," "expect,"
"predict," "scheduled," "new market," "potential market
applications" and similar expressions are intended to identify
forward-looking statements. Such statements are by nature subject
to uncertainties and risks, including but not limited to successful
patient enrollment in and timely implementation of the IDE clinical
studies for Essential Tremor and Parkinson's disease; receipt of an
IDE approval to conduct the Parkinson's disease study, which is not
assured; physician and patient acceptance of the Libra DBS system
for these DBS studies, for which already-approved products are
already available on the market; the uncertainty of clinical
results that may ensue from these clinical studies; the risk that
the FDA may not approve our PMA applications for these DBS products
or applications following the completion of the clinical trials;
competition from and the launch of new competitive products by
Medtronic, Advanced Bionics/Boston Scientific or others, as well as
other market factors that could impede growth in or reduce sales of
the Company's products, which could adversely affect revenues and
profitability; patient or physician selection of less invasive or
less expensive alternatives; adverse changes in coverage or
reimbursement amounts by Medicare, Medicaid, private insurers,
managed care organizations or workers' comp programs; intellectual
property protection and potential infringement issues; obtaining
necessary government approvals for other new products or
applications and maintaining compliance with FDA product and
manufacturing requirements; product liability; reliance on single
suppliers for certain components; completion of research and
development projects in an efficient and timely manner; the
satisfactory completion of clinical trials and/or market tests
prior to the introduction of new products; the cost, uncertainty
and other risks inherent in patent and intellectual property
litigation; and other risks detailed from time to time in the
Company's SEC filings. In addition, despite the encouraging results
reported in the Neuron article, there are limitations to this first
study of DBS for treatment-resistant depression. Sample size was
small, follow-up was limited, and no sham surgery or systematic
placebo control arm was used. There were also limitations on
identifying markers that might predict response. Differences in
electrode targeting and placement may have also contributed to the
observed response variance. The mechanisms of action of DBS are
incompletely understood. These and other factions require testing
of additional subjects. Consequently, if such management
assumptions prove to be incorrect or such risks or uncertainties
materialize, anticipated results could differ materially from those
forecast in forward-looking statements. Such forward-looking
statements speak only as of the date on which they are made, and
the Company does not undertake any obligation to update any
forward-looking statement to reflect events or circumstances after
the date of this release. DATASOURCE: Advanced Neuromodulation
Systems, Inc. CONTACT: investors, Neil Berkman Associates,
+1-310-277-5162, or , for Advanced Neuromodulation Systems, Inc.;
or Chris Chavez, President & CEO of Advanced Neuromodulation
Systems, Inc., +1-972-309-8000 Web site:
http://www.ans-medical.com/
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